A Research Study to See How Semaglutide Helps People With Excess Weight and Type 2 Diabetes Lose Weight
- Conditions
- ObesityDiabetes Mellitus, Type 2
- Interventions
- Drug: Placebo
- Registration Number
- NCT05649137
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This study will look at how much weight participants will lose and how much blood sugar control they achieve from the start to the end of the study. The weight loss in participants taking the investigational high dose of semaglutide will be compared to the weight loss in people taking "dummy" medicine and a lower dose of semaglutide. In addition to taking the medicine, participants will have talks with study staff about healthy food choices and how to be more physically active. Participants will either get semaglutide or "dummy" medicine. Which treatment participants get is decided by chance. Participants are more likely (4 out of 5) to get semaglutide than the "dummy" medicine. The study medicine will be injected briefly, under skin, with a thin needle, typically in the stomach, thighs, or upper arms. After receiving first dose, the dose of semaglutide will be gradually increased until reaching the target dose. The study will last for about 1.5 years.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 513
- Male or female.
- Age above or equal to 18 years at the time of signing informed consent.
- BMI greater than or equal to 30.0 kilograms per square meter (kg/m^2).
- Diagnosed with type 2 diabetes (T2D) greater than or equal to 180 days prior to the day of screening.
- History of at least one self-reported unsuccessful dietary effort to lose body weight.
- HbA1c 7.0-10.0 percent (53-86 millimoles per mole [mmol/mol]) (both inclusive) as measured by central laboratory at screening.
- A self-reported change in body weight greater than 5 kilograms (kg) (11 pounds [lbs]) within 90 days before screening irrespective of medical records.
- Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
- Renal impairment with estimated Glomerular Filtration Rate (eGFR) less than 30 milliliters per minute per 1.73 square meter (30 mL/min/1.73 m^2) (less than 45 mL/min/1.73 m^2 in participants treated with Sodium-glucose Cotransporter-2 [SGLT2i]) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation as defined by Kidney Disease: Improving Global Outcomes (KDIGO) 2012 by the central laboratory at screening.
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomization. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants will receive once-weekly s.c. injection of placebo matched to semaglutide for 72 weeks. Semaglutide 7.2 mg Semaglutide Participants will receive once-weekly injection of semaglutide subcutaneously (s.c.) in 20 week dose escalation period with dose escalation (0.25 milligram \[mg\], 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg, and 7.2 mg) every fourth week. Treatment will be continued on the maintenance dose of 7.2 mg once-weekly for an additional 52 weeks until week 72. Semaglutide 2.4 mg Semaglutide Participants will receive once-weekly s.c. injection of semaglutide in 20 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, and 2.4 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment will be continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks until week 72.
- Primary Outcome Measures
Name Time Method Semaglutide 7.2 mg versus Placebo: Number of participants who achieve body weight reduction greater than or equal to (>=) 5% (yes/no) From baseline (week 0) to end of treatment (week 72) Measured as count of participants.
Semaglutide 7.2 mg versus Placebo: Relative change in body weight From baseline (week 0) to end of treatment (week 72) Measured in percentage (%).
- Secondary Outcome Measures
Name Time Method Semaglutide 7.2 mg versus Placebo: Change in diastolic blood pressure From baseline (week 0) to end of treatment (week 72) Measured in mmHg.
Semaglutide 7.2 mg versus Placebo: Number of participants who achieve body weight reduction >=10% (yes/no) From baseline (week 0) to end of treatment (week 72) Measured as count of participants.
Semaglutide 7.2 mg versus Placebo: Number of participants who achieve body weight reduction >=20% (yes/no) From baseline (week 0) to end of treatment (week 72) Measured as count of participants.
Semaglutide 7.2 mg versus Placebo: Change in body weight From baseline (week 0) to end of treatment (week 72) Measured in kilograms (kg).
Semaglutide 7.2 mg versus Placebo: Change in low-density lipoprotein (LDL) cholesterol From baseline (week 0) to end of treatment (week 72) Measured in ratio to baseline.
Semaglutide 7.2 mg versus Placebo: Change in triglycerides From baseline (week 0) to end of treatment (week 72) Measured in ratio to baseline.
Semaglutide 7.2 mg versus Placebo: Number of participants with HbA1c less than or equal to (<=) 6.5 % (48 mmol/mol) From baseline (week 0) to end of treatment (week 72) Measured as count of participants.
Semaglutide 7.2 mg versus Placebo: Number of participants who achieve body weight reduction >=15% (yes/no) From baseline (week 0) to end of treatment (week 72) Measured as count of participants.
Semaglutide 7.2 mg versus Placebo: Change in waist circumference From baseline (week 0) to end of treatment (week 72) Measured in centimeters (cm).
Semaglutide 7.2 mg versus Placebo: Change in glycated haemoglobin (HbA1c) From baseline (week 0) to end of treatment (week 72) Measured in percentage (%).
Semaglutide 7.2 mg versus Placebo: Change in body mass index (BMI) From baseline (week 0) to end of treatment (week 72) Measured in kilograms per square meter (kg/m\^2).
Semaglutide 7.2 mg versus Placebo: Change in systolic blood pressure From baseline (week 0) to end of treatment (week 72) Measured in millimeters of mercury (mmHg).
Semaglutide 7.2 mg versus Placebo: Change in total cholesterol From baseline (week 0) to end of treatment (week 72) Measured in ratio to baseline.
Semaglutide 7.2 mg versus Placebo: Change in high-density lipoprotein (HDL) cholesterol From baseline (week 0) to end of treatment (week 72) Measured in ratio to baseline.
Semaglutide 7.2 mg versus Placebo: Change in very-low-density lipoprotein (VLDL) cholesterol From baseline (week 0) to end of treatment (week 72) Measured in ratio to baseline.
Semaglutide 7.2 mg versus Placebo: Number of adverse events (AEs) From baseline (week 0) to end of study (week 81) Measured as count of events.
Semaglutide 7.2 mg versus Placebo: Number of serious adverse events (SAEs) From baseline (week 0) to end of study (week 81) Measured as count of events.
Semaglutide 7.2 mg versus Placebo: Change in pulse From baseline (week 0) to end of treatment (week 72) Measured in beats per minute (bpm).
Semaglutide 7.2 mg versus Placebo: Number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes From baseline (week 0) to end of study (week 81) Measured as count of episodes.
Semaglutide 7.2 mg versus Semaglutide 2.4 mg: Number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes From baseline (week 0) to end of study (week 81) Measured as count of episodes.
Semaglutide 7.2 mg versus Placebo: Change in free fatty acids From baseline (week 0) to end of treatment (week 72) Measured in ratio to baseline.
Semaglutide 7.2 mg versus Placebo: Change in high-sensitivity c reactive protein (hsCRP) From baseline (week 0) to end of treatment (week 72) Measured in ratio to baseline.
Semaglutide 7.2 mg versus Placebo: Change in fasting plasma glucose From baseline (week 0) to end of treatment (week 72) Measured in milligrams per deciliter (mg/dL).
Semaglutide 7.2 mg versus Placebo: Change in fasting serum insulin From baseline (week 0) to end of treatment (week 72) Measured in ratio to baseline.
Semaglutide 7.2 mg versus Placebo: Number of participants with HbA1c less than (<) 7.0% (53 millimoles per mole [mmol/mol]) From baseline (week 0) to end of treatment (week 72) Measured as count of participants.
Semaglutide 7.2 mg versus Semaglutide 2.4 mg: Number of AEs From baseline (week 0) to end of study (week 81) Measured as count of events.
Semaglutide 7.2 mg versus Semaglutide 2.4 mg: Number of SAEs From baseline (week 0) to end of study (week 81) Measured as count of events.
Trial Locations
- Locations (67)
Univ of Alabama Birmingham
🇺🇸Birmingham, Alabama, United States
John Muir Physicians Network
🇺🇸Concord, California, United States
Velocity Clinical Research Westlake
🇺🇸Los Angeles, California, United States
Diablo Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States
New West Physicians PC
🇺🇸Golden, Colorado, United States
ARS- Deland CRU
🇺🇸DeLand, Florida, United States
Jacksonville Ctr for Clin Res
🇺🇸Jacksonville, Florida, United States
Florida Inst For Clin Res LLC
🇺🇸Orlando, Florida, United States
Oviedo Medical Research, LLC
🇺🇸Oviedo, Florida, United States
Hope Clin Res & Wellness
🇺🇸Conyers, Georgia, United States
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
PharmQuest Life Sciences LLC
🇺🇸Greensboro, North Carolina, United States
Amarillo Med Spec LLP
🇺🇸Amarillo, Texas, United States
Elligo Clin Res Centre
🇺🇸Austin, Texas, United States
Velocity Clin Res, Dallas
🇺🇸Dallas, Texas, United States
UT Southwestern Medical Center - Lingvay
🇺🇸Dallas, Texas, United States
PlanIt Research, PLLC
🇺🇸Houston, Texas, United States
DCOL Ctr for Clin Res
🇺🇸Longview, Texas, United States
Sugar Lakes Family Practice PA
🇺🇸Sugar Land, Texas, United States
National Clin Res Inc.
🇺🇸Richmond, Virginia, United States
Selma Medical Associates
🇺🇸Winchester, Virginia, United States
"MHAT-Blagoevgrad", Department of Internal Diseases
🇧🇬Blagoevgrad, Bulgaria
ET "Individual practice for specialized outpatient medical care - Dr. Georgi Marinov"
🇧🇬Burgas, Bulgaria
"Medical Center Viva Feniks" Ood
🇧🇬Dobrich, Bulgaria
UMHAT Pulmed, Department of endocrinology
🇧🇬Pazardzhik, Bulgaria
'MHAT Sveta Karidad' EAD
🇧🇬Plovdiv, Bulgaria
'MHAT Hadzhi Dimitar' OOD
🇧🇬Sliven, Bulgaria
"DCC VII - Sofia", Endocrinology Consulting Room
🇧🇬Sofia, Bulgaria
"UMHAT- Prof. dr. Stoyan Kirkovich"
🇧🇬Stara Zagora, Bulgaria
"MHAT "Sveti Panteleimon" - Yambol" AD
🇧🇬Yambol, Bulgaria
Ocean West Research Clinic
🇨🇦Surrey, British Columbia, Canada
G.A. Research Associates Ltd.
🇨🇦Moncton, New Brunswick, Canada
Nova Scotia Hlth Halifax
🇨🇦Halifax, Nova Scotia, Canada
Premier Clinical Trial Research Network (PCTRN)
🇨🇦Hamilton, Ontario, Canada
Wharton Med Clin Trials
🇨🇦Hamilton, Ontario, Canada
Milestone Research
🇨🇦London, Ontario, Canada
Lausmed Kft.
ðŸ‡ðŸ‡ºBaja, Bács-Kiskun Vármegye, Hungary
Belinus Bt.
ðŸ‡ðŸ‡ºDebrecen, Hajdu-Bihar Varmegye, Hungary
Borbánya Praxis E.Ü. Kft.
ðŸ‡ðŸ‡ºNyÃregyháza, Szabolcs-Szatmar Varmegye, Hungary
ClinDiab Egészségügyi Szolgáltató és Kereskedelmi Kft.
ðŸ‡ðŸ‡ºBudapest, Hungary
Bajcsy-Zsilinszky Kórház
ðŸ‡ðŸ‡ºBudapest, Hungary
MED-TIMA Kft.
ðŸ‡ðŸ‡ºBudapest, Hungary
Fejér Megyei Szent György Oktatókórház
ðŸ‡ðŸ‡ºSzékesfehérvár, Hungary
NZOZ "CenterMed Lublin" Sp. z o.o.
🇵🇱Lublin, Lubelskie, Poland
NZOZ Przychodnia Specjalistyczna Medica
🇵🇱Lublin, Lubelski, Poland
Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET
🇵🇱Krakow, Malopolskie, Poland
Kresmed Sp. z o. o.
🇵🇱Bialystok, Podlaskie, Poland
Uniwersyteckie Centrum Kliniczne SUM w Katowicach
🇵🇱Katowice, Poland
NBR Polska Tomasz Klodawski
🇵🇱Warszawa, Poland
PANSTWOWY INSTYTUT MEDYCZNY MSWiA
🇵🇱Warszawa, Poland
Unidade Local de Saúde de Matosinhos
🇵🇹Senhora da Hora, Matosinhos, Portugal
APDP - Associação Protectora dos Diabéticos de Portugal
🇵🇹Lisboa, Portugal
Centro Hospitalar de São João
🇵🇹Porto, Portugal
DIADA s.r.o.
🇸🇰Bardejov, Slovakia
DIADA, s.r.o.
🇸🇰Bardejov, Slovakia
Diab - Int, s.r.o.
🇸🇰Bytca, Slovakia
Diabetologicka ambulancia ENDOMED, s.r.o.
🇸🇰Kosice, Slovakia
MED-DIA CENTRUM s.r.o.
🇸🇰Povazska Bystrica, Slovakia
DIABETOL, s.r.o.
🇸🇰Presov, Slovakia
Phoenix Pharma
🇿🇦Port Elizabeth, Eastern Cape, South Africa
Medi-Clinic Bloemfontein
🇿🇦Bloemfontein, Free State, South Africa
Deepak Lakha
🇿🇦Johannesburg, Gauteng, South Africa
Hemant Makan
🇿🇦Johannesburg, Gauteng, South Africa
Wits Bara Clinical Trial Site
🇿🇦Johannesburg, Gauteng, South Africa
Dr N.K. Gounden Medical Centre
🇿🇦Durban, KwaZulu Natal, South Africa
Maxwell Centre
🇿🇦Durban, KwaZulu-Natal, South Africa
Dr T Padayachee
🇿🇦Umkomaas, KwaZulu-Natal, South Africa